SURGICAL BUR
FDA 510(k) clearance K943758 · decided 1994-08-22
Clearance details
- K-number
- K943758
- Device name
- SURGICAL BUR
- Applicant
- Komet Medical
- Decision
- Substantially Equivalent
- Date received
- 1994-08-02
- Decision date
- 1994-08-22
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- GFF
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Savannah, GA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ANSPACH SHIELDED ATTACHMENT (K974025) | The Anspach Effort, Inc. | 1998-07-06 |
| SURGICAL BUR (K950449) | Transidyne General Corp. | 1995-03-01 |
| BURRS (K934583) | American Medical Specialties, Inc. | 1994-01-26 |
| MICRO-AIRE CUTTERS FOR MIDAS-REX INSTRUMENTS (K894438) | Micro-Aire Surgical Instruments, Inc. | 1989-08-21 |
| DANEK IRRIGATING BURR (DIB) SET (K890090) | Danek Medical, Inc. | 1989-01-24 |
| KOMET SURGICAL BUR (K883255) | Komet Medical, Div. of Brasseler USA I, L.P. | 1988-09-15 |
| SURGICAL BURS (K880859) | New England Surgical Instrument Corp. | 1988-03-21 |
| SURGICAL BURS (K880706) | Nuell Air Equipment & Hospital Supplies, Inc. | 1988-02-26 |
| SURGICAL BUR (K872475) | Tava Surgical Instruments | 1987-07-02 |
| MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR (K862852) | Micro-Aire Surgical Instruments, Inc. | 1986-08-11 |
| BURS FOR MICRO SURGICAL DRILL SYSTEM (K853658) | Acumed Instruments Corp. | 1985-09-24 |
| MICRO-AIRE GENERIC BURS & DRILLS (K850497) | Micro-Aire Surgical Instruments, Inc. | 1985-03-01 |
Recalls involving this device
No recalls on record reference this clearance.